Medical Director – Dermatology (Senior)
Thermo Fisher Scientific · Lima
Descripcion del puesto
About the role
Thermo Fisher Scientific is seeking an experienced Medical Director (Senior) specialized in Dermatology to provide medical oversight for global clinical trials. You will ensure compliance with SOPs, client directives, Good Clinical Practice (GCP) and regulatory requirements while supporting business development and client interactions.
Key responsibilities
- Oversee clinical trial safety monitoring, including adverse events, laboratory abnormalities and protocol compliance.
- Review and analyze serious adverse events, ICSR, periodic safety reports (PBRER, PSUR, DSUR) and other regulatory deliverables.
- Present at investigator and sponsor meetings, providing medical consultation to clients, investigators and project teams.
- Assist in the preparation and review of CSR, IND/NDA reports, labeling reconciliation, CTD modules, REMS, RMP and related documents.
- Ensure delegated pharmacovigilance tasks are executed accurately and in line with ICH guidelines.
Required profile
- Medical degree with extensive experience in dermatology clinical research.
- Proven track record in pharmacovigilance and safety reporting for clinical trials.
- Strong understanding of GCP, ICH guidelines and regulatory requirements.
- Excellent communication skills to interact with investigators, sponsors and internal teams.
Required skills
- Good Clinical Practice (GCP)
- ICH guideline compliance
- Pharmacovigilance and safety monitoring
- Clinical trial adverse event assessment
- Regulatory document preparation (PBRER, PSUR, DSUR, CSR, CTD)
What we offer
- Opportunity to work on multinational clinical trials across 100+ countries.
- Access to cutting‑edge research resources and a collaborative scientific environment.
- Support for professional development and career advancement.
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Thermo Fisher Scientific
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